Table 3. Frequency of adverse events experienced by 2% or more of the patients in any one of the treatment group and all treatment-related adverse events during the 8-week double-blind trial (treated set) and long-term treatment period (treated set for T80/A5/H12.5).

	8-week double-blind period		8-week double-blind and/or open-label extension period
	T80/A5/H12.5 (n=68)	T80/H12.5 (n=64)	T80/A5/H12.5 a (n=68)	T80/H12.5 b (n=61)
Any AE	17 (25.0)	19 (29.7)	52 (76.5)	39 (63.9)
SAEs	0 (0.0)	0 (0.0)	2 (2.9)	0 (0.0)
Investigator-defined drug-related AEs	1 (1.5)	1 (1.6)	4 (5.9)	1 (1.6)
AEs leading to treatment discontinuation	0 (0.0)	2 (3.1)	3 (4.4)	0 (0.0)
All AEs
Infections and infestations	11 (16.2)	10 (15.6)	38 (55.9)	29 (47.5)
Nasopharyngitis	6 (8.8)	6 (9.4)	25 (36.8)	16 (26.2)
Respiratory tract infection	3 (4.4)	1 (1.6)	4 (5.9)	2 (3.3)
Pharyngitis	1 (1.5)	0 (0.0)	2 (2.9)	3 (4.9)
Gastroenteritis	0 (0.0)	0 (0.0)	3 (4.4)	0 (0.0)
Cystitis	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Helicobacter infection	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Pneumonia	0 (0.0)	0 (0.0)	1 (1.5)	2 (3.3)
Bronchitis	0 (0.0)	1 (1.6)	2 (2.9)	1 (1.6)
Influenza	0 (0.0)	1 (1.6)	2 (2.9)	1 (1.6)
Upper respiratory tract infection	1 (1.5)	0 (0.0)	2 (2.9)	1 (1.6)
Metabolism and nutrition disorders	0 (0.0)	1 (1.6)	2 (2.9)	6 (9.8)
Gout	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Nervous system disorders	3 (4.4)	1 (1.6)	6 (8.8)	5 (8.2)
Dizziness	0 (0.0)	0 (0.0)	2 (2.9)	1 (1.6)
Headache	2 (2.9)	0 (0.0)	2 (2.9)	1 (1.6)
Respiratory, thoracic and mediastinal disorders	2 (2.9)	2 (3.1)	13 (19.1)	5 (8.2)
Upper respiratory tract inflammation	2 (2.9)	1 (1.6)	6 (8.8)	1 (1.6)
Cough	0 (0.0)	0 (0.0)	2 (2.9)	1 (1.6)
Gastrointestinal disorders	1 (1.5)	1 (1.6)	11 (16.2)	14 (23.0)
Abdominal discomfort	1 (1.5)	0 (0.0)	2 (2.9)	3 (4.9)
Abdominal pain lower	0 (0.0)	0 (0.0)	3 (4.4)	0 (0.0)
Constipation	1 (1.5)	0 (0.0)	3 (4.4)	2 (3.3)
Diarrhea	0 (0.0)	0 (0.0)	1 (1.5)	2 (3.3)
Gastroesophageal reflux disease	0 (0.0)	0 (0.0)	2 (2.9)	2 (3.3)
Large intestine polyp	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Dental caries	0 (0.0)	0 (0.0)	2 (2.9)	0 (0.0)
Skin and s.c. tissue disorders	1 (1.5)	0 (0.0)	4 (5.9)	6 (9.8)
Eczema	0 (0.0)	0 (0.0)	2 (2.9)	3 (4.9)
Dermatitis	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Musculoskeletal and connective tissue disorders	1 (1.5)	3 (4.7)	8 (11.8)	9 (14.8)
Back pain	0 (0.0)	2 (3.1)	1 (1.5)	3 (4.9)
Muscle spasms	0 (0.0)	0 (0.0)	0 (0.0)	3 (4.9)
Arthralgia	0 (0.0)	0 (0.0)	0 (0.0)	2 (3.3)
Musculoskeletal pain	1 (1.5)	0 (0.0)	2 (2.9)	0 (0.0)
Musculoskeletal stiffness	0 (0.0)	0 (0.0)	2 (2.9)	0 (0.0)
General disorders and administration site conditions	0 (0.0)	1 (1.6)	3 (4.4)	4 (6.6)
Chest pain	0 (0.0)	1 (1.6)	1 (1.5)	2 (3.3)
Injury, poisoning and procedural complications	3 (4.4)	0 (0.0)	11 (16.2)	2 (3.3)
Fall	1 (1.5)	0 (0.0)	4 (5.9)	0 (0.0)
Treatment-related AEs
All treatment-related AEs	1 (1.5)	1 (1.6)	4 (5.9)	1 (1.6)
Metabolism and nutrition disorders	0 (0.0)	0 (0.0)	1 (1.5)	1 (1.6)
Hyperuricemia	0 (0.0)	0 (0.0)	1 (1.5)	1 (1.6)
Nervous system disorders	1 (1.5)	0 (0.0)	2 (2.9)	0 (0.0)
Dizziness	0 (0.0)	0 (0.0)	1 (1.5)	0 (0.0)
Loss of consciousness	1 (1.5)	0 (0.0)	1 (1.5)	0 (0.0)
Vascular disorders	0 (0.0)	0 (0.0)	1 (1.5)	0 (0.0)
Hypotension	0 (0.0)	0 (0.0)	1 (1.5)	0 (0.0)
Orthostatic hypotension	0 (0.0)	0 (0.0)	1 (1.5)	0 (0.0)
Investigations (laboratory data abnormalities)	0 (0.0)	1 (1.6)	1 (1.5)	0 (0.0)
Blood uric acid increased	0 (0.0)	1 (1.6)	1 (1.5)	0 (0.0)

Abbreviations: AE, adverse event; SAE, serious adverse event.

Values are presented as n (%).

T80/A5/H12.5, patients randomized to telmisartan 80 mg/hydrochlorothiazide 12.5 mg+amlodipine 5 mg in the double-blind treatment period; T80/H12.5, patients randomized to telmisartan 80 mg/hydrochlorothiazide 12.5 mg+placebo in the double-blind treatment period.

^aIncludes AEs that occurred in both the double-blind period and the extension period (for a total of 60 weeks) during treatment with T80/A5/H12.5.

^bIncludes AEs that only occurred in the extension period during treatment with T80/A5/H12.5 (for 52 weeks).